Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will be evaluated as first line treatment in metastatic breast cancer patients, with subsequent crossover to the opposite arm at disease progression or patient intolerance. We will explore this as well as any possible cross resistance between these two agents.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SCRI Development Innovations, LLC
• Collaborators: Aventis Pharmaceuticals; Ortho Biotech, Inc.
• Treatments: Docetaxel; Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

• Metastatic breast cancer confirmed by biopsy

• Prior adjuvant/neoadjuvant treatment allowed

• Measurable disease

• Able to perform activities of daily living with minimal assistance

• Age 18 years or older

• Adequate bone marrow, liver and kidney function

• Normal heart function

• Written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

• Pre-existing moderate peripheral neuropathy

• History of significant heart disease

• Meningeal metastases.

• Prior chemotherapy for metastatic breast cancer

• No measurable disease (including bone only, pleural effusions, etc.)

• Receiving Herceptin therapy.

• Women who are pregnant or lactating.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.